Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01868230
Recruitment Status : Recruiting
First Posted : June 4, 2013
Last Update Posted : October 26, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst

Brief Summary:
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy (~12 wks gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up will continue for one year postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Lifestyle Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
Behavioral: Lifestyle Intervention
No Intervention: Health and Wellness
Standard of care.

Primary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 10 weeks gestation ]
  2. Insulin Resistance [ Time Frame: 24 weeks gestation ]
  3. Insulin Resistance [ Time Frame: 34 weeks gestation ]
  4. Insulin Resistance [ Time Frame: 6 weeks postpartum ]
  5. Insulin Resistance [ Time Frame: 6 months postpartum ]
  6. Insulin Resistance [ Time Frame: 12 months postpartum ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Hispanic women
  • Overweight or obese before pregnancy (BMI >25 kg/m2)
  • 16-45 years old

Exclusion Criteria:

  • history of type 2 diabetes, heart disease, or chronic renal disease
  • contraindications to participation in moderate physical activity or to a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
  • inability to read English or Spanish at a 6th grade level
  • >20 wks gestation
  • current medications which adversely influence glucose tolerance
  • not planning to continue to term or deliver at the study site
  • pregnant with twins or triplets
  • preterm birth (<34 wks), a miscarriage, or a still birth after enrollment or a stillbirth
  • women who become pregnant again in the year following delivery will be censored at the time of their positive pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01868230

Contact: Lisa Chasan-Taber, ScD 413-545-1664
Contact: Megan W Harvey, MS 413-545-6732

United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Glenn Markenson, MD   
Principal Investigator: Glenn Markenson, MD         
Sponsors and Collaborators
University of Massachusetts, Amherst
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Lisa Chasan-Taber, ScD University of Massachusetts, Amherst

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lisa Chasan-Taber, Professor of Epidemiology, University of Massachusetts, Amherst Identifier: NCT01868230     History of Changes
Other Study ID Numbers: 1R01DK097011-01A1 ( U.S. NIH Grant/Contract )
1R01DK097011-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No